BIIB132 for Spinocerebellar Ataxias

Q: How many subjects are currently participating in this clinical experiment?

The clinical trial needs 48 eligible patients to begin. The sponsor, Biogen, will be running the study from locations including University of Pennsylvania in Philadelphia, and Research Site in San Francisco, California.

Q: Has BIIB132 been granted authorization from the FDA?

The safety of BIIB132 is estimated to score a 1 on our scale, as this Phase 1 trial has yet to provide sufficient evidence for both efficacy and safety.

Q: Is the age requirement for this clinical trial greater than 30 years?

The parameters for this research necessitate that participants are between 18 and 70 years old. There are, however, 33 trials targeting those older than 65 and an additional 18 clinical investigations available to minors.

Q: Who can participate in this medical research project?

If a person has spinocerebellar ataxia type 3 and is between 18 to 70, they may qualify for this investigational trial. This study will be recruiting 48 participants in total.

Q: How widely dispersed are the sites conducting this clinical research across America?

This trial is administered by 21 different sites, the most prominent of which are University of Pennsylvania in Philadelphia, Research Site in San Francisco, and UF Health Neuromedicine in New York. The remainder can be found at various other locations around the country.

Q: Are there presently opportunities for participants to enroll in this trial?

Yes, the information hosted on clinicaltrials.gov confirms that this medical trial is currently looking for applicants. The initial posting was February 2nd 2022 and it has been edited as recently as November 8th 2022. There are 48 openings spread out across 21 locations in total.

Universitaetsklinikum Essen, Essen, Germany

Spinocerebellar AtaxiasBIIB132 - Drug

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Eligibility

18 - 70

All Sexes

What conditions do you have?

Select

Eligibility

18 - 70

All Sexes

What conditions do you have?

Select

Study Summary

This trial is testing a new medication for safety and how well it works in people with spinocerebellar ataxia type 3.

Eligible Conditions

Spinocerebellar Ataxia Type 3

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Phase 1

Similar Trials

BIIB105

TCMCB07

DT-216

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Day 1 to Day 267

Day 267

Number of Participants with Adverse Events (AEs)

Day 85

Area Under the Concentration Versus Time Curve, from Time of Dosing (Time = 0) to Infinity (AUCinf) of BIIB132

Area Under the Concentration Versus Time Curve, from Time of Dosing (Time = 0) to Time of the Last Measurable Effect (AUClast) of BIIB132

Area Under the Concentration-Time Curve (AUC) of BIIB132

Elimination Half-Life (t½) of BIIB132

Maximum Observed Concentration (Cmax) of BIIB132

Time to Reach Maximum Observed Concentration (Tmax) of BIIB132

Screening to Day 267

Number of Participants with Serious Adverse Events (SAEs)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

BIIB105

TCMCB07

DT-216

Trial Design

11 Treatment Groups

BIIB132: Dose 3

1 of 11

Cohort 3: BIIB132 Dose 3 or Matching Placebo

1 of 11

Cohort 2: BIIB132 Dose 2 or Matching Placebo

1 of 11

Cohort 4: BIIB132 Dose 4 or Matching Placebo

1 of 11

BIIB132: Dose 1

1 of 11

BIIB132: Dose 2

1 of 11

BIIB132: Dose 4

1 of 11

BIIB132: Dose 5

1 of 11

Cohort 1: BIIB132 Dose 1 or Matching Placebo

1 of 11

Cohort 5: BIIB132 Dose 5 or Matching Placebo

1 of 11

BIIB132-Matching Placebo: Doses 1 to 5

1 of 11

Experimental Treatment

Non-Treatment Group

8 Total Participants · 11 Treatment Groups

Primary Treatment: BIIB132 · Has Placebo Group · Phase 1

BIIB132: Dose 3

Drug